{"id":4243862,"url":"https://alion.io/job/zimmer-biomet-development-sr-engineer-ii-sustaining","title":"Development Sr Engineer II - Sustaining","company":{"id":9247,"name":"Zimmer Biomet","domain":"zimmerbiomet.com","url":"https://alion.io/company/zimmer-biomet","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Phenom","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Diego, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":119000,"max":149000,"currency":"USD","period":"year","gross":null,"usd_annual":149000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"EU MDR","optional":false},{"name":"ISO 13485","optional":false},{"name":"SolidWorks","optional":false}],"status":"live","first_seen_at":"2026-11-13T12:18:48Z","employer_posted_date":"2026-11-13","last_verified_at":"2026-11-13T18:56:43Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.\nAs a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.\nWhat You Can Expect\nProvides technical leadership for Design History File remediation initiatives supporting the Iovera product line, including gap assessments, design control reconstruction, traceability establishment, objective evidence identification, and preparation of DHF documentation supporting regulatory inspections, technical documentation submissions, and product lifecycle compliance activities. Partners with cross-functional stakeholders to resolve historical documentation gaps, establish design traceability, and support internal audits, regulatory inspections, submissions, and product lifecycle activities.\nHow You'll Create Impact\nConducts comprehensive assessments of Design History Files to identify documentation gaps, missing objective evidence, and design control deficiencies.\nDevelops and executes remediation plans to correct, reconstruct, and close design documentation gaps.\nEstablishes and user needs, design inputs, design outputs, verification, validation, risk management, and design changes.\nPerforms technical reviews of historical engineering documentation to determine compliance with design control requirements.\nCoordinates cross-functional remediation activities involving Engineering, Quality, Regulatory Affairs, Clinical, Operations, and Manufacturing teams.\nAuthors and reviews remediation reports, gap assessments, engineering rationales, traceability matrices, and design control deliverables.\nSupports remediation of legacy product documentation to ensure completeness, consistency, and regulatory compliance.\nEnsures design changes, risk evaluations, verification, and validation activities are appropriately documented and linked within the DHF.\nPrepares and executes responses to design control nonconformances, audit observations, and regulatory findings.\nProvides technical leadership for remediation activities associated with CAPAs impacting design documentation or design controls.maintains traceability between \nWhat Makes You Stand Out\nLeadership of complex DHF remediation and design control compliance programs.\nIdeally you have parametric CAD modeling experience (SolidWorks is preferred).\nAdvanced knowledge of design controls and lifecycle documentation.\nDevelopment and remediation of Design History Files and supporting technical documentation.\nCreation and maintenance of requirements, traceability matrices, and design documentation structures.\nReview and assessment of design inputs, design outputs, verification, validation, and design change records.\nRisk management integration within the design control process.\nTechnical writing and documentation reconstruction for legacy products.\nRegulatory inspection readiness and audit support.\nCross-functional leadership and influence across Quality, Regulatory, Clinical, and Engineering disciplines.\nExperience with design controls under FDA Design Control requirements, ISO 13485, and EU MDR.\nExperience developing traceability matrices linking user needs, requirements, risks, verification, validation, and design changes.\nYour Background\nBachelor's Degree in Engineering and 5 years of relevant experience or equivalent experience required.\nB.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering,\nBioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering highly preferred.\nDemonstrated experience authoring, reviewing, maintaining, or remediating Design History Files (DHFs) and technical documentation.\n5 to 7 years of engineering work experience highly preferred. \nTravel Expectations\nUp to 5% travel might be required.\nExpected compensation for the role is $119,000 - 149,000 base per year plus performance bonuses.\nEOE","description_format":"text","description_chars":4648,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["Flexible schedule"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Surgical Instruments & Devices","Orthopedic & Spine Implants"],"lifecycle":[{"event":"open","at":"2026-11-13T12:18:48Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":30,"reasons":["conf:0","win:early","comp:brand"],"computed_at":"2026-11-13T19:21:50Z"},"pay":{"stated_usd_annual":149000,"is_top_pay":true},"html_url":"https://alion.io/job/zimmer-biomet-development-sr-engineer-ii-sustaining","json_url":"https://alion.io/job/zimmer-biomet-development-sr-engineer-ii-sustaining.json","meta":{"generated_at":"2026-11-13T19:21:50Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":38663,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":9247},"rest":"https://alion.io/mcp/rest/get_company?id=9247"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fzimmer-biomet-development-sr-engineer-ii-sustaining"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fzimmer-biomet-development-sr-engineer-ii-sustaining"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fzimmer-biomet-development-sr-engineer-ii-sustaining"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/zimmer-biomet-development-sr-engineer-ii-sustaining\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fzimmer-biomet-development-sr-engineer-ii-sustaining"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4243862}},{"tool":"search_jobs","arguments":{"company":"zimmerbiomet.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4243862},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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